According to the material, the Investigator's Brochure serves to document which of the following?

• A. The sponsor's budget approval
• B. The investigator's ability to recruit subjects
• C. The CRFs and amendments are approved by the site IRB
• D. Investigator and sponsor agreement to the protocol/amendments and CRF

Answer: (D)

The main idea here is that the Investigator’s Brochure is the document that helps both sponsor and investigator stay aligned on how the study will be conducted, including agreement to the protocol and any amendments and the data collection tools (the Case Report Forms) used to capture data. The IB provides essential information about the investigational product to support safety and study decisions, and it is distributed to investigators and reviewed by ethics committees. It isn’t about budgeting, the investigator’s ability to recruit subjects, or the IRB’s approval of CRFs. The agreement between sponsor and investigator to the protocol, its amendments, and the CRFs is what ties the study plan to the actual conduct, and the IB is the reference that accompanies those documents and updates as new information emerges.